The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Ctng For Use On Cobas 6800/8800 Systems.
| Device ID | K202408 |
| 510k Number | K202408 |
| Device Name: | Cobas CTNG For Use On Cobas 6800/8800 Systems |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Contact | Aradhana Karthikeyan |
| Correspondent | Aradhana Karthikeyan Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Product Code | QEP |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2021-01-21 |